Steerable Device For Introducing Diagnostic And Therapeutic Apparatus Into The Body

ABSTRACT

An apparatus including an elongate body having a lumen extending therethrough and a steering wire, having a distal portion defining a non-circular cross-section, associated with the distal portion of the elongate body.

BACKGROUND OF THE INVENTIONS

1. Field of Inventions

The present invention relates generally to devices that are used tointroduce diagnostic and therapeutic apparatus into the body.

2. Description of the Related Art

There are many instances where physicians must introduce diagnostic andtherapeutic apparatus, such as diagnostic and therapeutic electrodes,ultrasound transducers, biopsy devices and other surgical tools, intothe body. The diagnostic and therapeutic apparatus are often carried bycatheters, which allow physicians to gain access to the body in aminimally invasive manner by way of bodily lumens. In cardiac treatment,for example, a catheter is advanced through a main vein or artery intothe region of the heart that is to be treated.

One method of introducing diagnostic and therapeutic apparatus into thebody is to introduce a tubular member (typically a “sheath”) into thevicinity of the targeted region. A diagnostic or therapeutic apparatusis then passed through the tubular member to the targeted region. Ifnecessary, the diagnostic or therapeutic apparatus may be removed afterits function is performed, but the tubular member left in place, so thatother apparatus may be advanced to the targeted region to complete thediagnostic and/or therapeutic procedure.

Precise placement of the diagnostic or therapeutic apparatus is veryimportant, especially in those procedures concerning the heart. To thatend, some conventional sheaths are guided to the targeted region with asteerable catheter that is located within the sheath lumen. Once thesheath reaches the targeted region, the steerable catheter is removedfrom the sheath and a catheter carrying the diagnostic or therapeuticapparatus is advanced through the lumen. This type of sheath lacks anyonboard steering mechanism. As a result, redeployment of the distalportion of sheath, even to a region in close proximity to the initiallytargeted region, requires the withdrawal of the diagnostic ortherapeutic apparatus and the reintroduction of the steering catheter.

Other conventional sheaths include a steering mechanism that allows thephysician to deflect the distal portion of the sheath. The steeringmechanism consists primarily of one or more steering wires. One end ofeach steering wire is secured to the distal end of the sheath, while theother end is secured to a steering control device, such as the rotatingcam and steering control knob arrangement commonly found in steerablecatheters. Rotation of the control knob causes one of the wires toimpart a pulling force on the distal portion of the sheath, therebycausing the distal portion to deflect. To promote steerability, thedistal portion of the sheath (which is relatively short) is typicallyformed from relatively soft, flexible material. Conversely, the proximalportion (which is relatively long) is formed from relatively hard, lessflexible material that provides better torque transmission properties.

The inventors herein have determined that there are a number ofshortcomings associated with conventional steerable apparatus, such assteerable sheaths, that are used to introduce diagnostic and therapeuticapparatus into the body. For example, it is desirable to provide asheath or other tubular member having a small outer diameter (OD) inorder to limit the size of the entry hole that must be made in thepatient's vein or artery and to compensate for the effects ofarteriosclerosis. Because the diameter of the lumen, or inner diameter(ID), tends to be a function of the size of the diagnostic andtherapeutic apparatus to be introduced into the body, the primary methodof reducing the OD is reducing the wall thickness of the tubular member.

Heretofore, efforts to reduce wall thickness have been hampered by thefact that the wall strength of the tubular member distal portion must besufficient to prevent the steering wire from tearing through the distalportion during deflection. Proposed solutions to the strength problemincluded the use of harder materials and/or the addition of mechanicaldevices, such as coils, to the distal portion of the tubular member. Theinventors herein have determined that such solutions are less thanoptimal because they limit the flexibility and, therefore, thesteerability of the distal portion of the sheath or other tubularmember.

SUMMARY OF THE INVENTIONS

Accordingly, the general object of the present inventions is to providea apparatus that avoids, for practical purposes, the aforementionedproblems. In particular, one object of the present inventions is toprovide a steerable apparatus for introducing diagnostic and therapeuticapparatus into the body, such as a steerable sheath, having a thinnerwall than conventional apparatus without sacrificing steerability.

In order to accomplish some of these and other objectives, an apparatusin accordance with one embodiment of a present invention includes anelongate body having a lumen extending therethrough and a steering wire,having a distal portion defining a non-circular cross-section,associated with the distal portion of the elongate body. In onepreferred implementation, the elongate body is a sheath and the distalportion of the steering wire is substantially flat.

The present apparatus provides a number of advantages over conventionalsteerable apparatus for introducing diagnostic and therapeutic apparatusinto the body. For example, the non-circular steering wire distalportion distributes the forces generated during deflection over agreater surface area than a steering wire having a circularcross-section. The redistribution of forces over a greater area reducesthe amount strength required to prevent the steering wire from tearingthrough the distal portion of the tubular members, sheaths or otherelongate bodies during deflection. As a result, the present elongatebody may be made thinner than the tubular members, sheaths or otherelongate bodies in conventional steerable apparatus formed from the samematerial.

Use of the present non-circular steering wire also prevents out of planebending. The non-circular portion of the steering wire also provides alarger surface area for attaching the steering wire to the distalportion of the elongate body or an element within the elongate body,thereby making manufacturing easier and, due to the larger bonding area,decreasing the likelihood that the steering wire and elongate body withbecome disconnected.

The above described and many other features and attendant advantages ofthe present inventions will become apparent as the inventions becomebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of preferred embodiments of the inventions will bemade with reference to the accompanying drawings.

FIG. 1 is a plan view of a steerable apparatus in accordance with apreferred embodiment of a present invention.

FIG. 2 is a partial section view showing a steerable apparatus inaccordance with a preferred embodiment of a present invention, incombination with a catheter carrying a diagnostic or therapeuticelement, deployed within the heart.

FIG. 3 is a perspective, partial section view of an elongate body distalportion in accordance with a preferred embodiment of a presentinvention.

FIGS. 4 a and 4 b are side views of the elongate body distal portionillustrated in FIG. 3.

FIG. 5 is a perspective view of a steering wire and steering wireanchoring member assembly in accordance with a preferred embodiment of apresent invention.

FIG. 6 a is side view of an elongate body distal portion in accordancewith another preferred embodiment of a present invention.

FIG. 6 b is a top view of the elongate body distal portion illustratedin FIG. 6 a.

FIG. 7 a is side view of an elongate body distal portion in accordancewith still another preferred embodiment of a present invention.

FIG. 7 b is a top view of the elongate body distal portion illustratedin FIG. 7 a.

FIG. 8 is partial side section view of an elongate body distal portionin accordance with yet another preferred embodiment of a presentinvention.

FIG. 9 is a section view taken along line 9-9 in FIG. 1.

FIG. 10 is a partial cutaway view of the exemplary handle illustrated inFIG. 1.

FIG. 11 is a perspective view of a portion of the exemplary handleillustrated in FIGS. 1 and 10.

FIG. 12 is side partial section view of another portion of the exemplaryhandle illustrated in FIGS. 1 and 10.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

The detailed description of the preferred embodiments is organized asfollows:

-   -   I. Overview    -   II. Elongate Body Distal Portion    -   III. Elongate Body Proximal Portion    -   IV. Handle        The section titles and overall organization of the present        detailed description are for the purpose of convenience only and        are not intended to limit the present inventions.

I. Overview

The present inventions may be used within body lumens, chambers orcavities for diagnostic or therapeutic purposes in those instance whereaccess to interior bodily regions is obtained through, for example, thevascular system or alimentary canal and without complex invasivesurgical procedures. For example, the inventions herein have applicationin the diagnosis and treatment of conditions within the heart. Theinventions herein also have application in the diagnosis or treatment ofailments of the gastrointestinal tract, prostrate, brain, gall bladder,uterus, and other regions of the body.

As illustrated for example in FIG. 1, a preferred implementation of apresent invention is a steerable device 10 having a handle 12 and anelongate, hollow body 14. In the preferred implementation, the elongatebody 14 is a sheath having a lumen through which a catheter havingdiagnostic and/or therapeutic element(s) may be advanced.

The exemplary handle 12 consists partially of a handle body 16 and apiston 18. The piston 18, which is slidably mounted in a longitudinallyextending aperture in the handle body 16, includes a thumb rest 20. Thehandle body 16, piston 18 and thumb rest 20 are preferably formed frommachined or molded plastic. Other features of the exemplary handle 12are discussed below in Section IV. In the exemplary embodiment, one endof a steering wire 22 is secured to the distal portion 24 of theelongate body 14. The steering wire 22 passes through the proximalportion 26 of the elongate body 14 to the handle body 16, where theother end is secured. As discussed in Section III below, the elongatebody distal portion 24 and proximal portion 26 are joined to one anotherat a joint 25.

In the illustrated embodiment, the elongate body is secured to, andtravels with, the piston 18. As such, when the exemplary piston 18 ismoved distally from the position shown in FIG. 1, the steering wire 22exerts a pulling force on the distal portion 24 of the elongate body 14,thereby causing the distal portion of the elongate body to deflect intoa curved orientation.

Other types of steering apparatus may be used in place of the exemplarypiston-based configuration. For example, a handle may be provided thatincludes a rotating cam, to which the steering wire is connected, and asteering lever connected to the rotating cam. Manipulation of thesteering lever causes the steering wire to deflect the distal portion ofthe elongate body. This type of steering apparatus is disclosed in U.S.Pat. No. 5,636,634.

One exemplary use of the present steerable device is illustrated in FIG.2. Here, the distal portion 24 of the elongate body 14 has been insertedinto the heart and steered into the vicinity of targeted tissue withinthe left ventricle LV. It should be noted that the heart shown in FIG. 2is not exactly anatomically correct, and is shown in diagrammatic formto demonstrate the features of the exemplary device. A catheter 23 isextending from the distal portion 24 so that an element 25 (such as adiagnostic and/or therapeutic element) may be positioned adjacentmyocardial tissue.

II. Elongate Body Distal Portion

In accordance with a preferred embodiment of a present invention, and asillustrated for example in FIG. 3, the portion of the steering wire 22that is secured to the distal portion 24 of the elongate body 14 has anon-circular cross-section. Although other shapes may be employed, thedistal portion 28 of the exemplary steering wire 22 (also referred to asthe “non-circular portion”) is substantially flat and preferably free ofsharp edges that could damage the distal portion 24 of the elongate body14. A substantially flat steering wire distal portion 28 having a widthto thickness ratio between about 1.5 to 1 and about 10 to 1 ispreferred. The remainder of the steering wire (referred to herein as theproximal portion 30) has a circular cross-section.

The exemplary elongate body distal portion 24 illustrated in FIG. 3includes two lumens, a central lumen 32 through which diagnostic andtherapeutic apparatus may be advanced and a steering wire lumen 34 inwhich the steering wire 22 is located. The central lumen 32 preferablyterminates at the distal end 38 of the distal portion 24, therebydefining a distal end aperture through which diagnostic or therapeuticelements may exit the elongate body 14. However, the central lumen mayalso terminate in the side wall of the distal portion 24, therebydefining a side exit aperture. In the illustrated embodiment, thecross-sectional shape of the steering wire lumen 34 corresponds to thatof the substantially flat steering wire distal portion 28. This preventsunwanted rotation of the steering wire 22. However, the steering wirelumen 34 may have other cross-sectional shapes, such as an ellipticalshape, which will also prevent rotation of a non-circular steering wireor portion thereof.

As shown by way of example in FIG. 3, the steering wire 22 may besecured to an anchoring member 36 that is located within elongate bodydistal portion 24. The steering wire 22 may be secured to the anchoringmember 36 by, for example, welding or adhesive. The exemplary anchoringmember 36 is in the form of a cylinder. However, other shapes, such asan annular disk shape, could be used should they be required by aparticular application. The anchoring member 36 provides a relativelylong attachment surface, thereby decreasing the likelihood that thesteering wire 22 will become disconnected from the elongate body distalportion 24. In addition, the anchoring member 36 may be formed fromradiopaque material such as platinum or gold plated stainless steel. Theradiopacity allows the distal portion of the elongate body to beobserved by the physician using conventional fluoroscopic techniques.Other materials include rigid polymer and ceramic materials that arecompounded with radiopaque material.

There are a number of advantages associated with the preferredembodiment illustrated in FIGS. 1-3. For example, when the distalportion 24 of the elongate body 14 is deflected from the orientationshown in FIG. 4 a to the orientation shown in FIG. 4 b, the steeringwire will exert a force F along the elongate body distal portion. Inconventional devices employing pull wires having a circularcross-section, the distal portion wall must be relatively thick in orderto prevent the steering wire from tearing through the wall of the sheathor other elongate body. The wall in preferred embodiment illustrated inFIGS. 1-3 may be made thinner than conventional devices formed from thesame material because the exemplary substantially flat (or otherwisenon-circular) steering wire distal portion 28 distributes the force Fover a greater surface area than does a steering wire having a circularcross-section.

The use of the present non-circular steering wire also prevents out ofplane bending. In other words, when bending force is applied to theelongate body distal portion 24, it will bend about an axis that is bothperpendicular to the longitudinal axis of the elongate body and parallelto the width dimension of the steering wire non-circular portion 28. Thesteering wire non-circular portion 28 also provides a larger surfacearea for attaching the steering wire to the exemplary anchoring member36 (or other portion of the elongate body) than does a circular wire.

One utilization of the present invention is a steerable sheath that maybe used in cardiac treatments such as percutaneous myocardialrevascularization (PMR). In a preferred embodiment, the outer diameterof the elongate body 14 is about 0.118 inch and the diameter of thecentral lumen 32 is about 0.075 inch. The distal portion 24 of theelongate body is about 1.4 inches in length and should be flexibleenough to bend approximately 135° (note that a 90° bend is shown in FIG.4 b), yet have sufficient memory to return to its original orientationwhen bending forces are removed. To provide the necessary flexibility,the distal portion 24 of the elongate body may be formed from arelatively flexible material through a dual lumen extrusion process.Preferred relatively flexible materials include, for example,fluoropolymers such as THV 200, a commercially available combination oftetrafluoroethylene, hexafluoropropylene and vinylidene fluoride, andPellethane 80A. Radiopaque material, such as barrium, bismuth, andtungsten may be combined with the flexible material for visualizationpurposes.

In the exemplary steerable sheath that may be used in PMR and othercardiac care procedures, the anchoring member 36 is preferably about0.100 inch in length and has a wall thickness of about 0.002 inch. Thediameter of the circular proximal portion 30 of the steering wire 22 isabout 0.009 inch, while the width of the non-circular portion 28 rangesfrom about 0.012 inch to about 0.017 inch and the thickness ranges fromabout 0.003 inch to about 0.005 inch. To accommodate the non-circularportion 28, the steering wire lumen 34 has a shape corresponding to thatof the non-circular portion and cross-sectional dimensions which areabout 0.001 inch to about 0.003 larger than those of the non-circularportion. The length of the steering wire non-circular portion 28 ispreferably slightly less than that of the elongate body distal portion24. As a result, only the circular proximal portion 30 of the steeringwire 22 will pass through the circular steering wire lumen in theelongate body proximal portion 26 (discussed in Section III), even whenthe distal portion 24 is being bent. Alternatively, the non-circularportion 28 will extend the entire length of the elongate body distalportion 24 and the steering wire lumen in the elongate body proximalportion 26 will be modified accordingly.

Turning to FIG. 5, the steering wire 22 may be secured to the anchoringmember 36 prior to the insertion of both into the elongate body distalportion 24. The combined steering wire/anchoring member assembly may beinserted into the elongate body distal portion 24 as follows. Theelongate body distal portion 24 is heated to its softening temperature.The proximal end of the steering wire 22 is then inserted into thesteering wire lumen 34. The anchoring member 36 is moved toward theelongate body distal portion 24 until it reaches the distal end 38 ofthe distal portion. The anchoring member is then forced through thedistal end 38 of the softened distal portion 24 to the position shown inFIG. 3.

A stiffening member may be provided in order to prevent compression (orbuckling) of the elongate body distal portion 24 during bending, whichcan sometimes happen in those instances where the distal portion isformed with very thin walls or from very flexible material. As shown byway of example in FIGS. 6 a and 6 b, an alternative elongate body distalportion 24′ includes a stiffening member 40, which may be circular ornon-circular in cross-section, located in a stiffening member lumen 42.The stiffening member lumen 42 is itself located on the side of theelongate body distal portion 24′ opposite the steering wire 22 (andsteering wire lumen 34). The stiffening member 40 is bonded or otherwisesecured in place and is preferably formed from suitably rigid plastic orNitinol material. Referring to FIGS. 7 a and 7 b, another alternativeelongate body distal portion, identified by reference numeral 24″,includes a pair of stiffening members 40 respectively located in a pairof stiffening member lumens 42. Although other configurations may beemployed, the stiffening member lumens 42 in this embodiment are located90° from the steering wire lumen 34 and 180° from one another.

A stiffening member may also be used to maintain the cross-sectionalshape of the elongate body distal portion 24, which is circular in theillustrated embodiments. As illustrated for example in FIG. 8, analternative elongate body distal portion 24′″ includes a coil 44embedded therein to help maintain the circular shape of the distalportion. Of course, the coil 44 and steering wire lumen 34 (not visiblein FIG. 8) must be radially offset from one another within the distalportion 24′″.

III. Elongate Body Proximal Portion

As illustrated for example in FIG. 9, the exemplary elongate bodyproximal portion 26 includes an inner portion 46 through which a centrallumen 48 extends, a reinforcing element 50, and an outer portion 52. Thereinforcing element 50 increases the torque transmission properties ofthe proximal portion 26 and also increases its stiffness. The outerportion 52 includes a steering wire lumen 54 (note steering wire 22)which may be coated with a lubricious material 56 such as Teflon®.Although other material and structures may be used, the preferredreinforcing element is braided stainless steel having a braid patternand pick number suitable for the intended application. Exemplaryalternative reinforcing elements include double helix structures.Reinforcing elements, braided or not, may also be formed, for example,from Nylon® and other polymer materials.

The steering wire lumen 54 in the proximal portion 26 of the elongatebody 14 is aligned with the steering wire lumen 34 in the distal portion24. However, in contrast to the steering wire lumen 34, the steeringwire lumen 54 is preferably circular in cross-section. In thoseembodiments where the length of the non-circular portion 28 of thesteering wire 22 is less than the length of the elongate body distalportion 24, the steering wire lumen 54 in the proximal member may becircular in cross-section all the way to the distal end thereof. Inother embodiments, where the steering wire non-circular portion 28extends to the proximal end of the elongate body distal portion 24, thesteering wire lumen 54 may be either non-circular in its entirety, orsimply have a distal end that is chamfered into a funnel shape toaccommodate the non-circular portion.

As noted in Section II, one implementation of the present invention is asteerable sheath that may be used in cardiac treatments such as PMR.Here, like the elongate body distal portion 24, the proximal portion 26has an outer diameter of about 0.118 inch and the central lumen 48(which is aligned with the central lumen 32 in the distal portion) has adiameter of 0.075 inch. The length of the proximal portion 26 in thisimplementation may be about 7 inches to about 70 inches. Also, a strainrelief element (not shown) may be located over the proximal portion 26near the thumb rest 20.

The proximal portion 26 may be formed by first extruding the innerportion 46 over a mandrel. The reinforcing element 50 is then placedover the inner portion 46. Next, the outer portion 52, including thesteering wire lumen 54, is formed in a second extrusion. In thoseinstances where the surface of the steering wire lumen 54 includes thecoating of lubricious material 56, that coating is also formed duringthe second extrusion.

The distal and proximal portions 24 and 26 of the elongate body 14 aresecured to one another at the joint 25. The joint may be formed in avariety of ways. For example, an adhesive or thermal butt bondingtechnique may be used. However, the preferred method is an overlappingthermal bond. Specifically, the distal and proximal portions 24 and 26are arranged such that a small length of the distal portion overlaps theproximal portion (or vice versa). Heat is then applied to theoverlapping region, which causes the overlapping portions to bond to oneanother.

The inner and outer portions 46 and 52 are both preferably formed fromTHV 200, which is fairly lubricious. Here, the lubricious coating 56 isnot required. In other embodiments, the inner portion 46 is formed froma polyether block emide such as PEBAX®, which bonds well with anelongate body distal portion 24 that is formed from Pellethane, and theouter portion 52 is formed from a fluoropolymer such as THV 200. Instill other embodiments, the inner portion 46 is formed from afluoropolymer such as THV 200 and the outer portion 52 is formed from apolyether block emide such as PEBAX®. The lubricious coating 56 isespecially useful here.

IV. Handle

An exemplary handle that may be used in conjunction with the elongatebody 14 is the handle 12 illustrated in FIGS. 1 and 10-12. Similarhandles are commonly found in steerable catheters manufactured by EPTechnologies, Inc. under the trade name Polaris (, with one importantexception. The piston 18 in the present handle 12 includes a lumen thatconnects the central lumen in the elongate body 14 to an input port 58and a homeostasis valve 60. In the illustrated embodiment, the inputport 58 and hemostasis valve 60 are part of a Y-adapter 62 that iscapable of rotating 3600.

The exemplary piston 18 is a two-part assembly composed of a forwardpiston member 64 and a rear piston member 66. The forward piston member64 includes a main body 68 which supports a portion of the thumb rest 20at its distal end. The main body 68 extends into the handle body 16through a piston supporting cylinder 70. The piston supporting cylinder70 has o-rings at its longitudinal ends that center the main body 68. Asshown by way of example in FIG. 11, a lumen 72 extends through the mainbody 68 and terminates at a frusto-conical surface 74. The proximalportion 26 of the elongate member 14 extends through the lumen 72 andouter surface of the proximal end of the elongate body is bonded to theconical surface 74. A key way 75, which mates with a protrusion on theinner surface of the handle, prevents the piston from rotating.

The exemplary rear piston member 66 includes a conical tip 76 that mateswith the conical surface 74 (and distal end of the elongate body 14) anda cap 78 that fits over the forward member main body 68. The rear pistonmember 66 also includes a lumen 80 which feeds into the Y-adapter 62. Tothat end, the end 92 of the rear piston member 66 is inserted into thecylindrical portion 94 of the Y-adapter 62 and the two are sealed in arear sealing assembly 96. The adapter stem 98 rotates relative to thecylindrical portion 94 and an o-ring 100 is provided to create a seal.

The level of friction between the piston 18 and handle body 16 may becontrolled in part by a set screw 82 (FIG. 1) that imparts a force ontoa tab 84 on the piston supporting cylinder 70.

Turning to the steering wire 22 and the manner in which it may besecured within the handle 12, the main body 68 of the exemplary forwardpiston member 66 includes a slot 86 at its distal end. The rear pistonmember cap 78 includes a corresponding slot 88. The steering wire 22passes through the slots 86 and 88 and bends away from the central axisof the handle body 16. The distal end of the steering wire 22 is securedto an anchor 90 that is itself secured to the handle by a hollow nut andbolt assembly located on the half of the handle body 16 that is notshown in FIG. 10. Steering wire tension is set by rotating the boltrelative to the nut.

Although the present invention has been described in terms of thepreferred embodiment above, numerous modifications and/or additions tothe above-described preferred embodiments would be readily apparent toone skilled in the art. It is intended that the scope of the presentinvention extends to all such modifications and/or additions.

1-29. (canceled)
 30. An apparatus, comprising: an elongate body proximalportion having a proximal end and a distal end and including a wall,defining an inner surface, an outer surface and a central lumen thatextends from the proximal end to the distal end, and a steering wirelumen offset from the central lumen, located between the inner and outersurfaces of the wall, extending from the proximal end to the distal endof the elongate body proximal portion; an elongate body distal portionhaving a proximal end secured to the distal end of the elongate bodyproximal portion and including a wall, defining an inner surface, anouter surface and a central lumen extending from the proximal end of theelongate body proximal portion to a distal end aperture, and a steeringwire lumen offset from the central lumen, located between the inner andouter surfaces of the wall, extending from the proximal end to thedistal end of the elongate body distal portion; a coil located withinthe elongate body distal portion between the inner and outer surface ofthe wall and radially offset from the steering wire lumen; anchorlocated within the elongate body distal portion between the inner andouter surface of the wall and distal of the coil; and a steering wireextending through the steering wire lumens in the elongate body proximaland distal portions and secured to the anchor.
 31. An apparatus asclaimed in claim 30, wherein the proximal portion of the elongate bodyis relatively stiff and the distal portion of the elongate body isrelatively flexible.
 32. An apparatus as claimed in claim 30, whereinthe elongate body proximal portion steering wire lumen defines acircular cross-section, the elongate body distal portion steering wirelumen defines a non-circular cross-section, the steering wire has aproximal portion defining a circular cross-section and a distal portiondefining a non-circular cross-section, and the distal portion of thesteering wire is secured to the anchor.
 33. An apparatus as claimed inclaim 32, wherein the elongate body distal portion steering wire lumendefines a substantially flat cross-section.
 34. An apparatus as claimedin claim 33, wherein the steering wire distal portion defines asubstantially flat cross-section.
 35. An apparatus as claimed in claim34, wherein the elongate body distal portion steering wire lumen definescross-sectional dimensions that are about 0.001 inch to 0.003 inchgreater than those of the steering wire distal portion.
 36. An apparatusas claimed in claim 32, wherein the steering wire distal portion definesa proximal end, and the proximal end of the steering wire distal portionextends to the distal end of the elongate body proximal portion.
 37. Anapparatus as claimed in claim 30, wherein the anchoring member isdefines a substantially cylindrical shape.
 38. An apparatus as claimedin claim 30, wherein the elongate body proximal portion steering wirelumen abuts the elongate body distal portion steering wire lumen.
 39. Anapparatus as claimed in claim 30, wherein the distal end aperturecomprises an unobstructed distal end aperture.
 40. An apparatus asclaimed in claim 30, wherein the coil includes a plurality of spacesportions with elongate body distal portion material therebetween.
 41. Anapparatus as claimed in claim 30, wherein the anchor defines a distalend and the distal end of the anchor located proximal to the elongatebody distal portion distal end aperture.
 42. An apparatus as claimed inclaim 30, wherein the anchor is not a coil.
 43. An apparatus as claimedin claim 30, wherein the elongate body distal portion central lumen andthe coil define a common longitudinal axis.